EUCTR2021-003898-59-IT进行中（未招募）1 期
A Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) - .
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT0 个研究点目标入组 0 人开始时间: 2021年10月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Participants must be 18 years of age to 85 years of age inclusive, at the time of signing the informed consent
- •- Participants with a diagnosis of gMG at screening with generalized muscle weakness meeting the clinical criteria for diagnosis of MG, as defined by the MGFA Clinical Classification Class II, III, or IV, and likely not in need of a respirator for the duration of the study, as judged by the Investigator
- •- Positive serologic testing for anti-AChR or anti-MuSK autoantibody at screening OR
- •- Seronegative for both anti-AChR and anti-MuSK autoantibodies and with prior diagnosis supported by >/=1 of the following 3 tests:
- •a) History of abnormal neuromuscular transmission demonstrated by single-fiber electromyography or repetitive nerve stimulation
- •b) History of positive edrophonium chloride test
- •c) Participant has demonstrated improvement in gMG signs on oral acetylcholinesterase inhibitors as assessed by the treating physician.
- •- The participant must have a total score >/=6 on MG-ADL scale at screening and D1 with greater than half of the score attributed to non-ocular items
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- MGFA Class I (ocular MG) or Class V
- •- Participants having undergone thymectomy within 6 months of screening or having a planned thymectomy during the trial period.
- •- The participant has a history of infection or may be at risk for infection:
- •A history of active or latent tuberculosis (TB); Participants at risk of developing or having reactivation of hepatitis; Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals; Fever within 4 weeks of the Screening Visit (>/=38°C; however, if due to brief and mild ear, nose, throat viral infection participant may be included based on the Investigator's judgment); A history of infection with human immunodeficiency virus (HIV); A history of T-lymphocyte or T-lymphocyte-receptor vaccination, transplantation (including solid organ, stem cell, and bone marrow transplantation) and/or antirejection therapy.
- •- Any malignancy within the past 5 years prior Screening Visit (except for effectively treated carcinoma in situ of the cervix, adequately treated non-metastatic squamous or basal cell carcinoma of the skin and malignant thymoma that have been resected or are considered as cured by any treatment with no evidence of metastatic disease for >/=3 years) will be exclusionary
- •- Conditions that may predispose the participant to excessive bleeding
- •- Confirmed screening ALT >3 × ULN
- •- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究者
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